[exclusive] another variety passed the consistency evaluation, and 115 consistency acceptance numbers were analyzed as a whole

The latest Amoxicillin Capsules from Zhongshan branch of Zhuhai United Pharmaceutical Co., Ltd passed the consistency evaluation Acceptance No cyhb704834, original drug approval No.: gyzz h44021351, which is the first amoxicillin capsule in China to pass the consistency evaluation According to the data, Zhuhai federal government filed the reference preparation of 0.25g amoxicillin capsule as early as June 6, 2016, with Beecham Group PLC as the holder, which is consistent with the national catalog of reference preparation In December 2016, Zhuhai federal government filed the be of amoxicillin capsule, and carried out the be test with the professional title of "single dose, fasting and postprandial, random, open, two cycle, double cross bioequivalence study of amoxicillin capsule in healthy subjects" in the national clinical trial institution of West China Hospital of Sichuan University The first subject was enrolled on March 13, 2017 Day Recently, pemetrexed disodium for injection of Sichuan Huiyu Pharmaceutical Co., Ltd was accepted as the first injection reported for consistency evaluation At the same time, 50mg and 100mg of pemetrexed disodium for injection have been included in the list of drugs listed in China as early as 2017, accounting for two of the three injection specifications in the list of drugs listed in China, and the other is the moroxynidazole sodium chloride injection from hausen, Jiangsu Province Sichuan Huiyu Pharmaceutical Co., Ltd was founded in 2010 by Dr Ding Zhao, a young returnee after 85, in Neijiang, Sichuan Province In 2014, it passed the British GMP certification and became the first anti-cancer injection manufacturer in China to pass the British GMP certification The analysis of 115 acceptance numbers of conformity is well known At present, there are 115 acceptance numbers of conformity evaluation of generic drugs The former State Food and Drug Administration issued two batches of approval documents with a total of 22 Acceptance numbers, and three acceptance numbers are not approved Of course, according to the past approval and cycle, the industry also predicts that a number of people will pass the consistency evaluation in the near future The overall situation of consistency acceptance numbers is as follows: of the 115 acceptance numbers for consistency evaluation of quality and efficacy of generic drugs, 36 were declared in 2018, and 79 in 2017 The overall number is relatively small, after all, it is only 8 months since the end of 2018 Here is a brief look at the most popular varieties and the most active enterprises In terms of varieties, amlodipine besylate tablets have always been the focus of attention of enterprises, not only leading in application, but also ranking first in be filing At present, there are more than 30 clinical trials in China At present, 3 of the 7 acceptance numbers of rosuvastatin calcium tablets have been approved, among which Nanjing Zhengda Tianqing has also entered the list of drugs listed in China In terms of enterprises, Huahai pharmaceutical industry is undoubtedly the biggest winner However, on the whole, only 57 drug companies have accepted the consistency evaluation varieties, with the most acceptance numbers of 10, and most enterprises only have one or two acceptance numbers, so the task of each enterprise is still very heavy Which varieties can pass the consistency evaluation? I don't predict here I'm looking forward to the good news I believe that the third batch of varieties passing the consistency evaluation will be released soon For the specific progress information of consistency evaluation varieties, we can pay attention to the database of drug intelligence data registration and acceptance.